# K971597: Comfeel Purilon Gel,15G (3900)/Comfeel Purilon Gel,25G (3903)

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Jul 29, 1997 after 89 days
- Product code: NAE (Dressing, Wound, Hydrogel Without Drug And/Or Biologic)
- Device class: 1
- Regulation: 21 CFR 878.4022
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K926508 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926508: Intrasite Gel, Smith & Nephew United, Inc. (1993) Summary page 3.

## Indications for use
For use in the management of leg ulcers and pressure sores. The gel provides a moist wound healing environment which encourages natural autolytic debridement.

Source page: https://510kreport.com/device/K971597
Methodology: https://510kreport.com/methodology